Propofol Pharmacokinetics and Pharmacodynamics During Cardiopulmonary Bypass
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|ClinicalTrials.gov Identifier: NCT00622791|
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : February 25, 2008
Cardiopulmonary bypass (CPB) is known to alter pharmacokinetics (PK) and brain sensitivity to several drugs, including propofol. Few studies, however, have tested if propofol pharmacokinetical alterations observed after CPB could contribute to the increased hypnotic effect of propofol after CPB. This study was designed to test the hypothesis that changes in the PK of propofol contribute to an increase in its hypnotic effects after CPB as evidenced by changes in bispectral index (BIS) values.
Twenty undergoing coronary artery bypass graft patients will be allocated in two groups: 1) CPB groups and 2) off-pump coronary artery bypass graft. Bispectral Index values and blood samples for plasma propofol concentration measurements will be collected along the surgery and up to 12 hours in the post-operative period. Plasma propofol concentrations, Bispectral index values and propofol PK will be compared between the groups.
|Condition or disease|
|Coronary Artery Disease Cardiopulmonary Bypass Coronary Artery Bypass Graft|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Effects of Cardiopulmonary Bypass on Plasma Propofol Concentrations and Bis Values During Coronary Surgery|
Patients undergoing coronary artery bypass graft with cardiopulmonary bypass
Patients undergoing off-pump coronary artery bypass graft
- Propofol pharmacodynamics and pharmacokinetics
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622791
|Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo|
|São Paulo, Brazil, 05403000|
|Principal Investigator:||Maria M Carmona, MD PhD||Faculdade de Medicina da Universidade de São Paulo|